Shots:Health Canada has approved Opzelura cream 1.5% for the treatment of mild to mod. AD in children (≥2yrs.), when other topical therapies are ineffective or unsuitableApproval was based on the P-III (TRuE-AD3) trial, evaluating Opzelura (BID) vs vehicle in over 300 children (≥2 to <12yrs.) with ADTrial met its 1EP with more…
Shots:The FDA has approved Opzelura cream 1.5% for short-term and non-continuous treatment of mild to moderate AD in non-immunocompromised children (aged≥ 2), when other topical therapies are ineffective or unsuitablesNDA approval was based on the P-III (TRuE-AD3) trial which evaluated the safety and efficacy of ruxolitinib in over 300 children receiving 0.75%, 1.5%,…
Shots: ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…
Knight Therapeutics and Incyte Expand Latin America Agreement to Include Retifanlimab and Axatilimab
Shots:Knight Therapeutics has amended its agreement with Incyte Biosciences to gain exclusive distribution rights for retifanlimab (Brand name: Zynyz in the US and EU) and axatilimab (Brand name: Niktimvo in the US) in LATAMUnder the amended deal, Incyte will develop, manufacture, and supply retifanlimab and axatilimab, while Knight will handle regulatory approvals and…
Shots: Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…
Shots:The US FDA has approved Monjuvi (tafasitamab-cxix) + rituximab & lenalidomide for the treatment of adult pts with r/r follicular lymphoma (FL)Approval was based on the P-III (inMIND) trial assessing Monjuvi regimen vs PBO + rituximab & lenalidomide in adults (n=654) with r/r Grade 1 to 3a FL or r/r nodal, splenic or…
Shots:FDA has approved Zynyz (retifanlimab-dlwr) + Pt-based CT as 1L treatment of inoperable locally recurrent or metastatic SCAC, & as monotx. for locally recurrent or metastatic SCAC progressing on or intolerant to Pt-based CT; EMA & PMDA’s application are under reviewApproval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs…
Shots: Q1’2025 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The talk of the town remained Intra-Cellular Therapies’ acquisition by Johnson & Johnson for ~$14.6B The quarter highlighted breakthrough results, pivotal clinical data, including Eli Lilly and Incyte's P-III Study Data of Baricitinib to treat Alopecia Areata PharmaShots brings…
Shots:The 2 P-III (STOP-HS1 & STOP-HS2) trials assessed povorcitinib (45 or 75mg, QD, PO) vs PBO in mod. to sev. HS pts (≥18yrs.; n=600 each) for 12wks., followed by 42wk. extension & 30-day follow-up
STOP-HS1 met its 1EP, with povorcitinib (45 mg/75 mg) showing higher HiSCR50 rates at Wk. 12 (40.2%/40.6% vs 29.7%), while…
Shots:The P-III (BRAVE-AA-PEDS) trial assessed baricitinib (2 or 4mg, QD, PO) vs PBO in 257 pts (12 to <18yrs.) with severe AA, where 89% had significant scalp hair loss, 65% had minimal/no eyebrow hair, & 57% had minimal/no eyelash hair with ClinRO of 2/3; next cohort (6 to <12yrs) enrollment to start in 2026…

